LZI Cotinine II Enzyme Immunoassay
FDA 510(k) K192299 · Lin-Zhi International, Inc.
510(k) numberK192299
Submission
- Device name
- LZI Cotinine II Enzyme Immunoassay
- Applicant
- Lin-Zhi International, Inc.
Santa Clara, CA, US - Received
- August 23, 2019
- Decision date
- November 21, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MKU – Enzyme Immunoassay, Nicotine And Nicotine Metabolites
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3220
- Specialty
- Clinical Toxicology
Other 510(k)s with product code MKU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192517 | Psychemedics Microplate EIA for Cotinine in HairMKU · Traditional | Psychemedics Corporation | 04/22/2020SE |
| K062565 | Status DS Nicotine, Accusign Nicotine, Biosign NicotineMKU · Traditional | Princeton BioMeditech Corp. | 02/20/2007SE |
| K021944 | Cozart Eia Cotinine Urine KitMKU · Traditional | Cozart Bioscience , Ltd. | 05/14/2003SE |
| K974534 | Micro-Plate Cotinine EiaMKU · Traditional | OraSure Technologies, Inc. | 05/18/1998SE |
| K974234 | Micro-Plate Cotinine EiaMKU · Traditional | OraSure Technologies, Inc. | 05/14/1998SE |
| K972481 | Auto-Lyte Cotinine EiaMKU · Traditional | OraSure Technologies, Inc. | 10/21/1997SE |
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Questions and answers
When was LZI Cotinine II Enzyme Immunoassay cleared by the FDA?
LZI Cotinine II Enzyme Immunoassay (K192299) received a 510(k) decision of Substantially Equivalent on November 21, 2019, 90 days after the submission was received.
What is the product code of K192299?
The FDA product code is MKU – Enzyme Immunoassay, Nicotine And Nicotine Metabolites, a Class I (low risk) device regulated under 21 CFR 862.3220.